Grassley Statement on FDA’s Capability Assessments for European Union Member States

WASHINGTON
– Senate Finance Committee Chairman Chuck Grassley (R-Iowa) released the
following statement regarding the U.S. Food and Drug Administration’s (FDA) use
of the Mutual Recognition Agreement (MRA) with the European Union (EU) to help
ensure the safety and quality of prescription drugs in the United States.

“Anytime
the federal government can reduce inefficiencies and utilize taxpayer dollars
more productively, it should be commended. The U.S. Food and Drug
Administration’s efforts to update and implement a cooperative inspection
program with our allies in the European Union are aimed at ensuring patient
safety, improving the use of resources and reducing wasteful government
spending.

“These are
good faith efforts. However, the United States must remain vigilant and
aggressively oversee the program in order to keep inspection standards high and
ensure the safety and quality of our prescription drugs. While we trust our
allies to uphold stringent measures, we cannot become complacent or allow bad
actors to participate in this newly revived program. There have been too many
examples of failed quality controls coming from facilities in countries like
China and India to trust inspections without proper verification.”

According
to a statement released
by FDA, the MRA is designed to ease part of this burden and minimize
resource-intensive duplicative inspectional efforts by the U.S. and the EU. The
EU conducts similar inspections of establishments that manufacture medicines to
be used in the EU, so under the MRA, the FDA may rely on the inspectional
findings of EU member states in a European facility that will export to the
U.S., and an EU nation may accept the FDA’s inspectional findings at a U.S.
facility that exports to a nation in the EU.

In June,
Grassley sent a letter
to Department of Health and Human Services (HHS) Secretary Alex Azar and FDA
Acting Commissioner Norman Sharpless seeking information on the quality
controls for prescription drugs and their components manufactured in foreign
countries, specifically China and India. The letter also asks what the FDA is
doing to uphold safety standards in the United States, China, and India via
inspections of manufacturing facilities.

Reports
have noted that 80 percent of active pharmaceutical ingredients are produced in
China and India and that facilities in those countries have not maintained
adequate quality control standards.